Tissue access site system and method

ABSTRACT

A tissue access site system and methods for opening and closing a tissue access site are provided. A method for opening and closing an access site in a body lumen includes attaching a plurality of closure elements to a perimeter wall of a body lumen by advancing closure elements from an access and closure device associated with a guide wire positioned through the perimeter wall. A tissue cutting element of the access and closure device is advanced along the guide wire to cause the tissue cutting element to penetrate through the perimeter wall to open an access site in the perimeter wall that includes a plurality of tissue flaps. Each of the tissue flaps has a predetermined geometry and is attached to at least one of the closure elements. The closure elements are used to close the access site.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/002,767, filed Jan. 6, 2011, which application is a U.S. 371 NationalPhase Application of PCT/IL2009/000673, filed Jul. 6, 2009, which claimsthe benefit of U.S. Provisional Application No. 61/129,589, filed Jul.7, 2008 and U.S. Provisional Application No. 61/129,583, filed Jul. 7,2008, the entire contents of which are incorporated herein in theirentirety.

FIELD AND BACKGROUND

The present invention relates to a system and method foropening/dilating and closing a tissue access site and, moreparticularly, to a system which can be used to open/dilate and closelarge vascular access sites, such as those utilized in femoral vascularaccess.

More than five million percutaneous interventions are performed annuallyin the United States, involving femoral artery catheterization fordiagnostic or therapeutic purposes.

Most procedures are performed through small sheath access sites (5-8 F)and thus closure of such access sites can be effected using manual ormechanical compression for 15-30 minutes, typically combined with anextended bed-rest of three to six hours.

However, manual compression can cause patient discomfort, and istime-and resource-intensive, and as such, a need for quicker, morepatient compatible closure has led to the introduction of closuredevices in the early 1990s. Since then, vascular closure systems havebeen simplified to provide wider patient access to a range of vascularprocedures. Now available from many sources, these devices shortenprocedure times, allow patients to ambulate earlier, minimize bleedingand possibly reduce costs associated with hospital care.

At present there are dozens of devices on the market or at variousstages of development, such devices employ sutures, patches, glue,coagulants and/or staples or a source of energy to effectively sealaccess sites post procedure.

Although these devices were specifically designed for closure of smallaccess sites (<1 OF), there have been attempts since the late 90s toutilize suture closure devices (specifically the Sutura and Perclosedevices) in large bore access sites >18 F, illustrating at least alimited need for ‘automated’ closure of large access sites. Large boreaccess site closure is typically effected via manual suturing of anexposed artery and thus requires presence of a specialist while beingtime consuming as well as more invasive.

The studies performed to date illustrate that closure of access sitesless than 18 F in size via such devices is effective and highlysuccessful, whereas closure of larger bore access sites (e.g. 22 F) isless effective.

Although at present the number of procedures effected through large boreaccess sites is small, current trends anticipate that the number of suchprocedures will rise in the future and although a concomitant reductionin sheath sizes might also take place, such reduction will still placeaverage sheath size at over 18 F.

While reducing the present invention to practice, the present inventorshave devised an access site system which provides the physician withcontrol over access site generation and closure.

BRIEF SUMMARY

According to one aspect of the present invention there is provided atissue access site system comprising: (a) an element designed forgenerating a tissue access site through a tissue, the tissue access sitebeing surrounded by tissue edge portions of a predetermined geometry;and (b) a tissue closure device being for attaching at least one closureelement to the tissue at a region corresponding to at least one of thetissue edge portions.

According to another aspect of the present invention there is provided amethod of providing access through tissue comprising: (a) cuttingthrough a tissue to generate a tissue access site surrounded by tissueedge portions of a predetermined geometry; (b) attaching at least oneclosure element to the tissue at a region corresponding to at least oneof the tissue edge portions; and (c) using the tissue access site togain access through the tissue.

According to further features in preferred embodiments of the invention,step (b) is effected prior to step (a).

According to still further features in the described preferredembodiments the tissue cutting element is designed for cutting a crosspattern through the tissue.

According to still further features in the described preferredembodiments the tissue cutting element is designed for generating atissue edge portion having a triangular geometry.

According to still further features in the described preferredembodiments the tissue cutting element is designed for cutting thetissue access site going into the tissue.

According to still further features in the described preferredembodiments the tissue cutting element is designed for going into thetissue through and cutting the tissue access site coming out of thetissue.

According to still further features in the described preferredembodiments the at least one closure element is a suture and furtherwherein the tissue closure device includes at least one tissue piercingelement.

According to still further features in the described preferredembodiments the system is configured for coordinating operation of thetissue cutting element and the tissue closure device, such that at leastone closure element is attached to the tissue at a 10 regioncorresponding to at least one of the tissue edge portions prior to,during or following generation of the tissue access site.

According to still familiar features in the described preferredembodiments the tissue closure device is a suturing device capable ofthreading a suture in and out of the tissue.

According to still further features in the described preferredembodiments the at least one closure element is a clip.

According to still further features in the described preferredembodiments the tissue cutting element and the tissue closure device areintegrated into a single housing.

According to still further features in the described preferredembodiments the system further comprises a patch delivery device fordelivering a patch to the tissue.

According to still further features in the described preferredembodiments the system further comprises an adhesive or sealant deliverydevice.

According to yet another aspect of the present invention there isprovided a method of performing a procedure requiring access throughtissue comprising: (a) cutting through a tissue to generate a tissueaccess site surrounded by tissue edge portions of a predeterminedgeometry; (b) attaching at least one closure element to the tissue at aregion corresponding to at least one of the tissue edge portions; (c)performing the procedure through the tissue access site; and (d) closingthe tissue access site using the at least one closure element.

According to still further features in the described preferredembodiment s step (b) is effected prior to step (a).

According to still another aspect of the present invention there isprovided a tissue access site system comprising: (a) a tissue dilatingelement designed for dilating a hole in a tissue; and (b) a tissueclosure device being for attaching at least one closure element to thetissue around the hole.

According to still further features in the described preferredembodiments the tissue dilating element is designed for positioning overa guide-wire.

According to still further features in the described preferredembodiments the tissue dilating element is designed for controllablydilating the hole so as to minimize tissue damage around the hole.

According to still further features in the described preferredembodiments the at least one closure element is a suture and furtherwherein the tissue closure device includes at least one tissue piercingelement.

According to still further features in the described preferredembodiments the system is configured for coordinating operation of thetissue dilating element and the tissue closure device, such that atleast one closure element is attached to the tissue around the holeprior to, during or following dilation thereof.

According to still further features in the described preferredembodiments the tissue closure device is a suturing device capable ofthreading a suture in and out of the tissue.

According to still further features in the described preferredembodiments the at least one closure element is a clip.

According to still further features in the described preferredembodiments the tissue dilating element and the tissue closure deviceare integrated into a single housing.

According to still another aspect of the present invention there isprovided a device for generating an access site in a tissue comprising ablade having a cutting pattern capable of forming an access site havingone or more flaps of tissue.

According to still another aspect of the present invention there isprovided a balloon catheter configured for accessing an ipsi-lateralblood vessel from a contralateral entry site.

According to still further features in the described preferredembodiments, the balloon catheter includes a compliant balloon.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a system which can be usedto control access site generation and closure.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIGS. 1A-B illustrate two tissue cutting patterns demonstrating theresulting edge portion geometry formed by the tissue cuts.

FIG. 2 illustrates the triangular edge portions resulting from a crossshaped cut pattern provided with puncture holes for enabling attachmentof tissue attachment elements.

FIG. 3 illustrates the head portion of the system of the presentinvention showing the blade guides through which the cutting blades aredeployed.

FIGS. 4A-B illustrate the cutting element in a deployed positionprotruding out of the head portion of the system of the presentinvention (FIG. 4A is a 10× magnification of the region circled in FIG.4B).

FIG. 5 illustrates the cutting element removed from the housing of thesystem of the present invention showing the four cutting blades.

FIG. 6 illustrates the closure device assembly which includes foursuture guides.

FIGS. 7 A-C illustrate closure element attachment to the tissue andsubsequent access site generation using the system of the presentinvention.

FIGS. 8A-B, 9A-C, 10A-C, 11A-B, 12A-E, 13A-C, 14A-D and 15A-B illustrateaccess site generation and closure according to the teachings of thepresent invention as demonstrated on a phantom model simulating atissue-embedded blood vessel.

FIGS. 16, 17 and 18 illustrate an embodiment of a system incorporatingdilator and suture closure functions.

FIG. 19 illustrates one embodiment of a securing element constructed inaccordance with the teachings of the present invention.

FIGS. 20, 21, 22, 23, 24 and 25 illustrate use of the contra lateralsystem of the present invention in closure of an arterial access site.

DETAILED DESCRIPTION

The present invention is of a system for complete or partial closure ofa tissue access site and optionally of creating the access site andpreparing it for subsequent closure. Specifically, the present inventioncan be used to close or reduce an access site to a lumen of a hollowtissue structure such as a vessel while also optionally enablingcontrolled generation of the access site and preparation thereof forclosure or reduction.

The principles and operation of the present invention may be betterunderstood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

Access to body cavities and lumens of organs and vessels can be achievedthrough tissue access sites. For example, in the case of percutaneousvascular procedures, a tissue access site created through a wall of anartery enables a physician to guide and deploy various instrumentsthrough the lumen of the artery.

The size of the access site depends on the type of procedure andinstrument used. Though most types of procedures utilize relativelysmall access sites (<8 F) which can be later closed via manualcompression, such compression can cause patient discomfort, and istime-and resource-intensive, and as such, a need for quicker, morepatient compatible closure has led to the introduction of closuredevices.

Such devices were specifically designed for closure of small accesssites, however, introduction of procedures that require larger accesssites, such as percutaneous valve replacement, trans- or intra-aorticpump placement and AAA repair 15 has initiated attempts to utilizeclosure devices in large bore access sites (>12 F) illustrating a needfor ‘automated’ closure of large access sites.

While reducing the present invention to practice, the present inventorshave identified a need for a closure system that would enable efficientclosure of large bore access sites as well as small bore access sites.

The present inventors postulated that in order for such a system to beeffective in closing large bore access sites, control over access sitegeometry and placement of closure elements is crucial.

Vascular access sites are presently generated by inserting a dilatingsheath into a needle puncture hole in the blood vessel. The dilatingsheath dilates the blood vessel tissue to a desired size at which pointthe dilating sheath is either replaced or used as the working sheath.Dilation of the access site and subsequent manipulation of the workingsheath can result in vascular tissue tearing and damage around theaccess site thus severely impacting subsequent closure.

As is further described hereinunder, the present system incorporates atissue cutting/nicking element for generating a tissue access site of aprescribed shape (e.g. geometry of formed edge portions) and size and atissue closure device which is capable of attaching tissue closureelements (e.g. sutures) at specific tissue regions around the accesssite, thereby optimizing tissue attachment of the closure elements. Thepresent inventors believe that the unique combination of controlledtissue cutting and precise closure element attachment provides a tissueaccess site which is capable of maintaining access site integritythroughout a procedure while at the same time facilitates subsequentclosure while ensuring maximal closure efficacy.

Thus, according to one aspect of the present invention there is provideda system for creating a tissue access site and for preparing the accesssite for subsequent closure (also referred to herein as “tissue accesssite system” or the “present system”).

The present system includes two independently actuatable componentswhich can be integrated into a single housing or be separately housed.

The first component includes a tissue cutting/nicking element which isdesigned for facilitating the generation of a tissue access site througha tissue. The tissue can be any tissue which defines a wall of a cavitywithin the body or a lumen of a vessel.

Examples of tissue include vascular tissue, abdominal tissue and thelike.

The tissue cutting/nicking element is configured such that the accesssite formed thereby is surrounded (defined) by tissue edge portionshaving a predetermined geometry.

Regardless of the cut pattern or extent of cutting (e.g., nicking orcomplete cut), tissue cutting is effected in a way which enablesubsequent introduction of a medical instrument through the access siteformed by the cut. For example, the tissue can be completely cut to forman access site which enables direct introduction of the medicalinstrument, or it can be partially cut and then controllably dilated(via, for example a dilator) to generate the access site. In cases wherethe tissue is partially cut (e.g. nicked or scored), forcible dilationof the nicked or scored tissue can lead to controllable tissue reapingand generation of an access site of a desired size.

In any case, when used to generate a vascular access site, the presentinvention facilitates introduction of a medical instrument through aworking sheath which is first introduced into the access site andprovides a conduit for the medical instrument (e.g., catheter). Toaccommodate the medical instrument or sheath (which can have a bore sizeas large as 24 F or more) the tissue cut is selected such that the edgeportions generated by the cut or nick in the tissue can be folded intothe lumen of the tissue when a medical device is pushed through theaccess site, essentially acting as push-in flaps. Such folding providesthe largest possible access site while minimizing tissue stress whichcan lead to tissue tearing and alteration to access site shape and size.

FIGS. 1a-b illustrate various tissue cutting patterns which result inpredefined edge portion geometry and predefined access site shape andsize. FIG. 1a illustrates a cross-shaped cutting pattern which resultsin four triangular tissue edge portions each having a 90 degree angle,while FIG. 1b illustrates a V-shaped cutting pattern which results in av-shaped flap. Other cutting patterns can include a Y, U or straightradial or axial cutting patterns. In any case, the cut is effected suchthat the dimension of the formed access site are smaller than theworking sheath inserted therethrough, thus minimizing any blood leakageduring a procedure. For example, an X or V-shaped cut pattern can beeffected such that the resulting access site is about 12-18 F in sizeand is dilated to fit a 22 F sheath.

The tissue cutting element includes a tissue cutting head which isconfigured for cutting the pattern through the tissue. The cutting headcan be configured to cut the tissue from the outside of the tissue andinto the lumen, or in the reverse direction when exiting the lumen ofthe tissue. In the latter case, a cutting head having deployable cuttingblades can be introduced into the lumen of the tissue through a smallpuncture (e.g. 3 F) and the blades deployed within the lumen. Thecutting head can then be pulled out of the tissue to generate the cutpattern. A stopper element can be incorporated into the cutting blade orthe cutting head to serve as a stop against the tissue thus preventingany damage to peripheral tissues. For example, in the case of an artery,such a stopper element can be positionable above the blades such thatwhen the blades cut through the artery wall, the stopper element wouldstop further cutting into the tissue when the blades reach apredetermined depth.

The cutting head can include blades (e.g. fabricated from stainlesssteel, Nitinol, ceramic and the like) wires (e.g. cauterization wires),water jets, a sonic scalpel or any device capable of cutting tissue.Cutting blades are preferred for their relatively simple operation andaccuracy; FIGS. 3-6 below provide a detailed description of a cuttingelement and cutting head capable of generating an access site having across cutting pattern.

A second advantage to cutting an access site having predefined shape andsize and predefined edge portion geometry is in the preparation of thesite for closure.

As is mentioned hereinabove, prior art approaches for generating accesssites do not have control over the geometry of the resultant access siteand tissue flaps surrounding it, thus leading to difficulties insubsequent closure, especially in cases where closure is effected viasuturing.

It will be appreciated that although the cutting head is described incontext of the present system, such a cutting head can also be designedso as to serve as a retrofit option for existing suturing devices. Forexample, the cutting head can be positioned using a frame which can befitted over an existing suturing device (e.g. Perclose), oralternatively a frame can be used as a reference for guiding the cuttinghead and then subsequently and separately guiding a suturing device,thereby generating an access site surrounded by sutures optimallypositioned around the edges of the access site cut.

The present system further includes a tissue closure device which servesfor attaching one or more closure elements to the tissue at a regioncorresponding to at least one, preferably all of the tissue edgeportions.

The tissue closure element can be a suture, a clip (e.g. a Nitinol wireclip), a patch or a combination thereof. In any case, the closureelement is configured for attachment to, the edge portion tissue in amanner which enable subsequent use of the closure element(s) todraw/attach the edge portion together and close the access site.

The tissue closure elements can be attached through the tissue from theinside of the lumen or from the outside. In the case of suture materialor Nitinol wires, the closure element can be threaded through the tissueone or several times and drawn out of the tissue through the centeraccess hole, though the side slits defining the edge portions or throughthe tissue itself. The free end of the suture or wire can then beutilized to manipulate/orient the edge portions so as to draw the edgeportions together and ensure a tight closure.

FIG. 2 illustrates exemplary attachment sites (puncture holes) throughwhich closure elements can be attached to or through four triangularedge portions of a cross shaped access site cut. The closure elements inthis case can be suture threads that are threaded from the outside ofthe tissue into the lumen and drawn out of the center hole of the accesssite.

Attachment of the closure elements can be effected prior to, during orfollowing cutting of the access site.

For example, (and as is shown in FIGS. 7a-c ), closure elements (e.g.sutures) can be introduced through a site in the tissue (e.g. a wall ofa blood vessel) which corresponds to the edge portions formed by asubsequent cut pattern; the free ends of the closure elements can thenbe positioned within the lumen of the tissue (e.g. lumen of a bloodvessel). Following the cut, the closure elements free ends (e.g. suturefree ends) can then be captured by a suture drawing element (e.g. suturegrabbing hook(s) which can be a part of the present system) and drawnout of the tissue through the access site hole. Attachment of theclosure elements prior to tissue cutting is advantageous in that theuncut tissue provides better resistance to the movement of the closuredevice and thus facilitates piercing of the tissue and introduction ofthe closure elements therethrough.

Closure elements can also be introduced through the tissue during thecutting of the access site. In such a scenario, the cutting element canbe deployed along with the closure device and the cut and closureelement attachment can be effected simultaneously to generate a cutpattern with free edge portions which are attached to closure elements.The closure elements can extend from outside the tissue and into theclosure site, in which case such elements can be introduced through theoverlying tissue (e.g. through the skin and fat layers overlying anartery). Such an approach can be advantageous in that suture typeclosure elements can be introduced through the skin and underlyingtissue and through the tissue surrounding the access site.

It will be appreciated that closure elements can be delivered throughthe overlying tissue without having to engage such tissue. For example,a suture type closure element can be delivered through the skin andunderlying tissue and into the tissue surrounding the access site, aanchoring element (e.g. T-bar or disc) can then be deployed on thetrailing end of the suture to act as a backstop against the outersurface of the access site tissue. In such a case the suture isdelivered (via, for example, a needle) through the tissue but it is notretained therein, but is rather maintained against the tissuesurrounding the access site via a backstop.

In an alternative embodiment, the closure elements can be introduceddirectly into the tissue of surrounding the access site. In such a case,the cut in the overlying tissue can be used for directly accessing theaccess site tissue and for attaching closure elements directly theretowithout having to deliver the closure elements through the overlyingtissue.

Attachment of the closure elements following tissue cutting requiresthat the free tissue edge portions be stabilized in order to facilitateintroduction of the closure elements through the tissue. Suchstabilization can be provided by dedicated elements or by the cuttingblades which can act to force the tissue edge portions against the forceof the closure device. Alternatively, tissue stabilization can beprovided by a balloon which is inserted over a guide-wire and inflatedwithin the lumen of the tissue (e.g. lumen of a blood vessel).

FIGS. 3-7 illustrate one specific embodiment of the present system whichis configured for generating vascular access sites and preparing suchsites for closure.

In this configuration of the present system, the closure elements aresutures/wires which are attached to the tissue around the access siteprior to tissue cutting. The sutures/wires are introduced into thetissue (e.g. blood vessel) via needles that are prepositioned near theintended location of the cut and function in puncturing the tissue anddelivering the wires/sutures into the tissue. The present system caninclude a mechanism which enables to verify that the needles are all inposition prior to deployment of the sutures/wires such that they aredelivered into the tissue and the suture free ends are positioned so asto enable subsequent capturing and withdrawal from the tissue. Forexample, in the case of blood vessels, the needles can be deployed intothe lumen and checked for blood flow which indicated lumen penetration.

Alternatively, the needles can be preformed such that they curve inward(towards the access site) following delivery into the lumen of thetissue. Such a feature can be enabled by using pre-curved needles orneedle guides (e.g. pre-curved Nitinol needles) which are maintainedstraight in the delivery head and curve inward upon release therefrom orby using a hinging needle assembly.

The cutting element of such a system is configured for creating anarterial access site which can be used for percutaneous procedures. Thecut pattern is selected such that it generates an access site which canbe used for large bore as well as small bore access with minimalnon-elastic deformation to the access site thus enabling the access sitetissue to return to its precut position. Closure of the access site isachieved via sutures which are attached to the edge portions of theaccess site prior to the procedure.

The present system can be deployed at the site of interest (e.g. anarterial wall) through a cut made in the overlying tissue (skin and fat)made by a scalpel. Alternatively, the present system can be deployedagainst the skin overlying the artery with the cutting head and closureelements delivered through the overlying tissue and arterial wall.

The system described below includes a single housing which integratesboth the cutting element and closure device, both separately operable.

FIGS. 3-6 illustrate the present system which is referred to hereinbelowas system 10.

As is illustrated in FIGS. 3-4 b, system 10 includes a housing 12 whichincludes a shaped cutting element tract 14 for guiding the movement of ashaped cutting element 16 (shown in FIGS. 4a -5) out of and into housing12. A cross shaped cutting blade and tract are illustrated in FIGS. 4a-5; other configurations can include a straight blade, a v-shaped bladeas well a three flange blade or any configuration suitable for creatinga controlled cut in the tissue. Housing 12 can be molded or machinedfrom a metal (e.g. stainless steel) or a polymer (e.g. polypropylene) acombination thereof using techniques well known to the ordinary skilledartisan.

Cutting element 16 moves along tract 14 and out of housing 12 to cut across-shaped pattern through the tissue. Head portion 18 of housing 12is angled (30-60 degrees) in order to provide an angle of operation withrespect to the tissue. Cutting element 16 moves out of head portion 18,to a position in which blades 20 of cutting element 16 are capable ofcutting through a wall of an artery while not damaging the interiorwalls of the blood vessel.

FIG. 5 illustrates cutting element 16 out of housing 12. The cross shapecutting element includes four blades that move as a single unit althoughconfigurations in which each of the blades move separately are alsoenvisaged.

The preferred cutting angle is 45°. Cutting blades 20 drive through astroke which is limited by a stopper in housing 12 or disposed on blades20. The stroke is determined and adjusted according to the tissuetreated. In the case of arteries it is typically between 10 and 20 mm.In case of a simple straight cut or a V cut the cut is made by a singleblade structure (that can be constructed from one or two blades). Thistype of cut will be perpendicular to the lumen axis. The length of astraight cut would normally be 4-8 mm; the thickness of the blades isnormally −0.1 mm. In the more complex configurations, e.g. cross shapedblades, non-symmetric blades can be used such that a symmetric cut isformed when used in a 45 degree cutting angle.

Blades 20 of cutting element 16 are arranged around a central rod 22which also includes a central bore 24 which can run the length ofhousing 12 and is designed for receiving a guide-wire or needle. Theneedle and/or guide-wire can be used for initial positioning of System10 against the blood vessel as is further described hereinbelow withrespect to FIGS. 7a -c.

Housing 12 also includes channels 26 for guiding tubes 28 which form apart of closure device 30 (shown in FIG. 6). tubes 28 are designed forejection out of channels 26 of housing 12 and penetration through thearterial wall. Such ejection can be provided via triggered springelements or ejection arms.

System 10 further includes proximal handles and connecting arms (notshown) for separately operating cutting element 16 and closure device30. The handles can be compressed to push cutting element 16 and tubes28 out of housing 12 and against the wall of the artery. Closure device30 and/or cutting element 16 may further include a safety mechanism toprevent premature operation. System 10 may further include a lockingmechanism for preventing cutting element 16 and/or closure device 30from being advanced past a predetermined point. This mechanism ensuresthat cutting element 16 and/or closure device 30 do not accidentallydamage internal arterial tissue.

Closure elements formed as wires composed of a metallic, preferablyNitinol head (wire leader) and a metallic or polymericsuture/wire/thread (wire tail) are 25 preloaded into tubes 28 (onewire/suture per tube 28). The wire leader may include a tissue piercinghead for penetrating through tissue or such tissue piercing can beeffected by tubes 28. The wire leader further includes an engagingfeature (e.g. small hook) which is designed for engaging a receiverelement which can be positioned on central rod 22 or blades 20 ofcutting element 16.

Such a receiver (not shown) can be a mesh configured for engaging thewire leader within the lumen of the artery or a hook configured forgrabbing the wire tail and drawing it out through the access site formedby cutting element 16. The mesh or hook can be deployable from centralrod 22 to expand in order to engage the wire leader. For example, a meshstructure can be sequestered (compressed) within central rod 22 andexpanded (much the same as a stent) to form a net like structure whichcan trap the wire leader which can be provided with a hook or aball-like protrusion. Following trapping of the wire leader the mesh andattached wires can be retracted and withdrawn out of the access site.

In the case where 4 wires are utilized, the wire tail can terminate in aT-bar or disc-shaped anchoring element which functions as a backstopagainst the skin or the outside wall of the artery. Such an anchoringelement can be preloaded into channels 16 along with the wire andsuture. The anchoring element can be forced out of tube 28 via a pushrodprovided therein or simply by pulling on the free ends of the wires(withdrawn through the access site). In cases where the wires aredelivered through overlying tissue, the anchoring element can be securedagainst such overlying tissue (e.g. skin), or delivered through theoverlying tissue and deployed against the tissue surrounding the accesssite (e.g. outer arterial wall).

When two wires are utilized, i.e. loaded into the four tubes 28, suchthat each pair of tubes 28 carries a single looped wire (with the loopend sequestered within housing 12), the free ends of the wires aredelivered into the tissue and recovered as is described above with loopof each wire functioning as a ‘backstop’.

FIGS. 7a-c illustrate the operation of system 10 against an artery 40.

An artery such as a femoral artery is exposed using a minimal tissue cutand a needle is driven through the arterial wall at a 45 degree angle tocreate a hole for inserting a guide-wire into the lumen 42 of theartery. Accurate placement of the needle is indicated by blood flow outof the needle bore (not shown). A guide-wire 44 is inserted into theartery through the needle bore and the needle is removed.

Housing 12 of system 10 is mounted over guide-wire 44 (shown in FIG. 7b) and system 10 is positioned through the tissue and over an outsidesurface of wall 46 of artery 40 such that head portion 18 of housing 12fully contacts wall 46 and housing is angled with respect to artery 40at approximately 45 degrees.

Tubes 28 (not shown) are moved into position against wall 46 and thewires are forced through wall 46 and into lumen 42 of artery 40 suchthat the wire leader is disposed within the artery while the tailportion protrudes out of the arterial wall with the backstop stillmaintained within channels 26 of housing 12.

With the wire leaders disposed within lumen 42, cutting element 16 isdeployed (pushed out of tract 14 within housing 12) through wall 46 tocreate a cross-shaped cut through the tissue. Blades 20 or central rod22 which are now disposed within lumen 48 of artery 40 engage the wireleaders within lumen 42 of artery 40. Retracting cutting element 16 backinto housing 12 pulls the wires out of lumen 42 through the tissue cut.Further retraction of cutting element out of the formed access siteand/or retraction of housing 12 out of the tissue further pulls wiresout of the tissue cut and frees the wire tail 10 (and included backstop)from tubes 28.

Complete withdrawal of housing 12 out of the body pulls out the headportion of the wires outside the body and secures backstop againstoutside surface of wall 46.

System 10 can now be completely removed leaving behind a cross-shapedcut having triangular edge portion each fitted with a wire suture goinginto the artery at the edge portion and out through the center of theincision. The wires may be individually color coded to allowidentification of each with respect to its position around the accesssite.

A working sheath can then be inserted through the cut tissue by forcingthe edge portions and attached wires inwardly into lumen 48. Aprocedure, such as abdominal aortic Aneurysm (AAA) or percutaneous valvereplacement (e.g. AVR) can then be performed through the sheath.Throughout the procedure, the free leader portions of the wires aremaintained outside the body (e.g. taped against the skin around the skinincision).

Following the procedure, the sheath is pulled out and edge portion areallowed to retract back up to partially close the access site. The wiresare then utilized to close the access site and prevent leakage of bloodtherethrough.

Several closure schemes can be utilized. Since the wires exit lumen 48through the center of the access site from the center of the incision,one or more securing elements (e.g. tie rings, clips or patches) can bepushed along the wires from outside the body and against the arterialwall 46. The securing element(s) can secure the wires via frictionadhesive and the like, or alternatively, the wires can be knotted overthe securing element(s). In any case, the wires are secured such thatthe edge portions are forced against each other and around the cut.Compression is applied to the sutures (and therefore the cut site) untilleakage is no longer detected and then the wires are secured via thesecuring element and the ends are cut and removed from the tissue.

Such securing elements can be used to secure the wires into a singlebundle or to secure pairs of the wires. In any case, the securingelement is pushed over the wire from outside the body and up against thearterial wall. Pushing can be effected with a dedicated tool with adistal end configured for holding the securing element(s), moving italong the wires and releasing it at the site of the arterial wall.

An advantage of such securing element is that it prevents the wires fromapplying excessive pulling forces on the tissue when the access site isclosed.

The securing element can be a clip for clipping together the wires or abutton. The clip/button can be fabricated from a bio-absorbable materialsuch as a polymer composed of poly-glycolic and/or polylactic acid units(e.g. PGA, PLA or PLGA).

One example of securing element is shown in FIG. 19. As is illustratedin this Figure, the securing element is disposed within the access sitewhile the first ends of the wires/sutures are co-threaded through acentral hole of the securing element and the second ends are loopedabove the securing element or attached thereto (prior to, or followingpositioning of the securing element).

This exemplified configuration of a securing element is disc shaped andincludes a central hole for accepting the ends of the wires/suturesutilized for closure. The securing element of FIG. 19 is designed forplacement within the access site such that the tissue edges of theaccess site abut the circumference of the securing element. The disc canbe designed such that the tissue edges abutting its circumference fitwithin a circumferential slot (e.g. grommet shaped). A securing elementthat functions as a plug (rather than a patch) provides a tighter sealwhile reducing the forces of the sutures/wires on the tissue duringclosure.

This configuration of the securing element can be used as follows, theend of the sutures (4-6 sutures) coming out of the access site, arethreaded through the center hole of the securing element. The centerhole can then be crimped (plastic deformation) to hold the suturestogether while the proximal ends (coming out of the center hole) are cutor are tied together.

The opposing suture ends are gently pulled (in a proximal direction) andthe element is advanced (pushed from the top and pulled by the sutures)into the access site to a point where the securing element engages thetissue around the access site.

Once the element is in place the sutures ends that were pulled are tiedto each other above the element to achieve tight contact of arterytissue and the closure element while sutures ends are cut proximally toknot.

Although withdrawal of the wires through the cut site is preferred,other configurations of system 10 in which the wires are stitchedthrough the tissue are also envisaged. In such cases, the closure deviceincludes a stitching head which enables threading of the wires into andout of the arterial wall. For example, a stitching head having curvedneedles which penetrate the arterial wall from the outside and curveback out can be used to thread one or more wires around the access site.

It will be appreciated that the present system can also be utilized toreduce the access site size (to, for example, 6-8 F) rather thancompletely close it. In such cases less suturing is requires (e.g. twostitches on in each ‘arm’ of a V-shaped access site cut) and completeclosure can be effected via a sealant, an adhesive or apatch/sponge/plug or the like which can be administered using thepresent system or a separate device (e.g. tissue adhesive dispenser).

Thus, the present invention provides a system for access site generationand closure. The present system provides several advantages over priorart approaches including:

-   -   (i) known cut geometry minimizes distortion/tearing of the        access site during dilation and procedure;    -   (ii) enables accurate closure since the suture is placed        accurately with respect to the cut and since multiple sutures        are placed with accuracy with respect to one another; and    -   (iii) reduces residual narrowing of the lumen at the closure        site;    -   (iv) Reduces risk of sutures misplacement (sutures that do not        grab tissue or grab minimal tissue portions);    -   (v) Securing element reduces forces of sutures on tissue and        maintains force symmetry-minimizes risk of suture tearing        through tissue.

The present invention also encompasses a system which combines thefunctions of a dilator and a closure device.

Thus, according to another aspect of the present invention, the closuredevice described above is integrated with the function of a dilator suchthat closure elements are attached to the tissue surrounding a hole(e.g. a needle puncture) prior to or during dilation of the hole togenerate an access site.

Such a system integrates (preferably in a single housing) a tissuedilating element which is designed for dilating a hole in a tissue (e.g.a conically shaped, guide-wire guided dilator sheath) with the tissueclosure device described herein.

FIGS. 16-18 illustrate a system for dilating and suturing an access sitewhich is referred to herein as system 100.

System 100 includes a dilator portion 102 which is hingedly attached toa central shaft 103 (via hinge 105) which runs through a stitchingportion 104 (which can be translated along central shaft 103). Centralshaft 103 includes a collector 108 which is 15 configured for actuationbetween open (radially expanded, FIG. 18) and closed (radiallycollapsed, FIG. 17) positions. Stitching portion 104 and part of dilatorportion 102 are covered by sheath 106 which when pulled back(proximally) exposes a hinge portion 105 which enables articulation ofdilator portion 102 with respect to central shaft 103 and stitchingportion 104. This articulation enables positioning of stitching portion104 at the access site while dilator portion is positioned within andalong the artery. Stitching portion 104 includes needle guides 110(containing needle pushrods) which are exposed and deployed when sheath106 is pulled back to the open position. Needles guides 110 andcontained pushrods are configured for delivering needles and attachedsutures through the arterial wall and into the artery lumen. Collector108 is configured for capturing needles and attached sutures when in theopen position. Once needles and attached sutures are delivered andcaptured, sheath 106 is closed to actuate collector 108 to the closed(collapsed) position and to thereby retain the sutures.

System 100 is utilized as follows, the artery is exposed and puncturedwith a needle or a cutting element 16. A guide wire is inserted into theartery and a dilator portion 102 of system 100 is positioned over thewire and utilized to dilate the access site to a size of about 12 F.Stitching portion 104 is then pushed along central shaft 103 up againstthe access site and sheath 106 is pulled back to open collector 108(mounted on central shaft 103 and positioned within the lumen of theartery) and allow angulation (70-90 degrees) between dilator portion 102and stitching portion 104. System 100 is pulled back until collector 108is juxtaposed against the inner wall of the artery, such that collector108 pushes against the inner artery wall around the access site. Needleguides 110 are then deployed and the pushrods are utilized to driveneedles (and attached sutures) through the artery wall and intocollector 108.

The needles will penetrate the artery wall in predefined angle and willengage collector 108 at a predefined location (see FIG. 18). Needleguides 110 are then pulled back leaving the needles and attached suturesattached to collector 108. Sheath 106 is then pushed to a closedposition to close collector 108 thereby locking the needles and attachedsutures to central shaft 103.

System 100 is then optionally further advanced into artery (about100-200 mm) to extend suture length into the artery to prevent trappingof suture thread at the access site. Stitching portion 104 remains inposition while central shaft 103 and attached dilator portion 102 arepulled out through the center of stitching portion 104 and out of thebody. Removal of central shaft 103 pulls the sutures ends attached tocollector 108 through the access site and out of the body, the sutureends can then be released from collector 108. The stitching portion isthen removed and a catheter can then be positioned over the wire andadvanced through the access site and used in a medical procedure. Oncethe medical procedure is completed, the suture ends disposed outside thebody can be used to close the access site as described above.

It will be appreciated that although the system described above isadvantageous in that it enables preparation of an access site forsubsequent closure or reduction, an access site, whether generated usingthe controlled cutting element of the present invention or not, can alsobe reduced or closed via alternative approaches.

Thus, according to another aspect of the present invention there isprovided a system and method for closure of an arterial access siteusing a contra lateral closure component. As is further described below,such a contra lateral closure device preferably functions cooperativelywith an ipsi lateral device. However, it will be appreciated that use ofthe contra lateral component alone is also envisaged herein.

Closure of a tissue access site using a system which includes a contralateral device and an ipsi lateral device is illustrated in FIGS. 20-25.Briefly, the ipsi-lateral component includes an 18G needle and a 350micron guide-wire, as well as a dilation kit which includes a set of 12to 24 fr dilators and a 24 F introducer/sheath with a depth marker and a14-18 F flex guide/sheath with shaped tip. The tip is configured forenabling passing of the contra-lateral guide-wire over the ipsi-lateralguide-wire (and co-positioning of both) and is typically shaped as asoft (elastic) conic snub nose tip about 50-75 mm in length with adistal diameter of about 1-3 mm, and a proximal diameter of about 6-18mm. The tip can also include channels/grooves along the length thereoffor further facilitating passage of the contra-lateral guide-wire.

The contra-lateral component includes a needle and guide wire (standard)and a deployable tubular element which is 4-5 F in a foldedconfiguration and 22-28 F in an open (deployable) configuration. Thetubular element is typically 20-30 mm long and is configured as a rolledup sheet, a wire mesh with a partial or a complete cover, or a tube withsolid walls composed of a biodegradable material. The contra-lateralcomponent further includes a 6 F guide catheter with pre-shaped tip andexternal 24-28 F compliant balloon (silicone) and an optional small holeclosure device (Standard).

The present system can be used with a 22-28 F sheath with/without thepre-procedure controlled cut (FIG. 20).

Once the procedure is done, an access from the ipsi-lateral side isachieved (using known approaches), a guide-wire is inserted to the ipsiiliac and a 6 F guide catheter is placed over the guide-wire while the22-28 F sheath and wire are pulled to mid iliac.

Once the guide catheter is located in the ipsi-lateral iliac distal enda safety occlusion is performed by inflating the 22-28 F element/balloon(FIG. 21).

The 22-28 F ipsi-lateral sheath is then fully retracted and the 14-18 Fsheath (with the special tip described above) is guided over theipsi-lateral guide-wire back to mid iliac to allow the contra-lateralguide-wire to progress down over the ipsi-lateral access site hole (FIG.22).

Once the contra-lateral guide-wire is in location, a folded tubularelement (e.g. wire tubular element with a polymeric or tissue cover) isinserted from the contra-lateral access site over the contra-lateralguide-wire to be located over ipsi access hole (FIGS. 23-24). All theabove steps are preformed while monitoring and adjusting the blood flowusing the balloon occlusion.

The 14-18 F flex sheath is removed and the graft position across thehole is verified. The graft is then deployed (via inflation or releasemechanisms—similar to those utilized in stents or stent grafts) and theintegrity of the closure is verified by checking for blood leaks fromthe ipsi-lateral access site (FIG. 25).

The contra-lateral catheter and guide catheter are then removed alongwith the wire and the contra-lateral access site is closed using any oneof several known approaches. The ipsi-lateral access site hole can thenbe closed using sutures, patch, an adhesive or the like. As used hereinthe term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting. Additionally, each of the various embodiments and aspects ofthe present invention as delineated hereinabove and as claimed in theclaims section below finds experimental support in the followingexamples.

EXAMPLE

Reference is now made to the following example, which together with theabove descriptions, illustrate the invention in a non limiting fashion.

A phantom model was used to simulate access site generation and closure.A silicon tube 50 (OD 9 mm, ID 7 mm) was wrapped with raw chicken breasttissue 51 and a jig 52 for guiding needles and cutting blades was usedto simulate the operating head of the present system. The jig 52 wasmachined from aluminum as a round disc 54 having a 45 degree tissueinterface angle and a cross shaped slot 56 and four holes 58 for guidingthe blades and needles respectively (see FIGS. 8a-b and 9a-c ).

In the first step, illustrated in FIGS. 8a-b , a needle 60 was insertedthrough the tissue 51 and silicone tube 50 at a 45 degree angle asguided by the jig 52. A guide-wire can then be inserted through theneedle into the lumen of the silicone tube 50. The guide-wire can thenbe used to guide the system through suture insertion and cutting. Sincein the phantom model a jig is used to simulate the operational head ofthe present system, use of a guide-wire is not needed.

The suture needles 62 were then inserted through the tissue 51 and intothe lumen of the silicone tube 50 (FIGS. 9a-b ) and a cutting blade 64was utilized to cut a straight radial cut pattern in the silicon tubewall to generate the access site (FIG. 9c ).

Sutures (4-0) 66 were then threaded through the four needles 62 and intothe lumen of the silicon tube 50 (FIGS. 10a-c ).

The free ends 68 of the sutures 66 were captured within the lumen andwithdrawn from the silicone tube 50 and tissue 51 through the centralneedle 60 and the jig 52 was removed while the sutures 66 remained inthe tube 50 and tissue 51 (FIGS. 11a-b ). A dilator 70 was then insertedbetween the suture ends 68 and through the tissue 51 and access site 72in the silicone tube 50 (FIGS. 12a-e ), such dilation does notappreciably deform the cut site or surrounding silicone. Followingaccess site dilation, a tube 74 simulating a 22 F working sheath (shownin FIG. 12e ) was inserted through the access site 72. To close theaccess site 72, the suture central ends 68 were pulled out and a bead 76(acting as a clip) was threaded along the 4 sutures 66 down through thetissue 51 and up against the silicon tube outer wall 78. The free ends68 of the sutures 66 (protruding from the tissue 51) were drawn tightand tied and the access site 72 closed (FIGS. 14a-d ). FIGS. 15a-b showthe resultant external (FIG. 15a ) and internal closure (FIG. 15b ).

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub-combination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

What is claimed is:
 1. A method for opening and closing an access sitein a body lumen, the method comprising: attaching a plurality of closureelements to a perimeter wall of a body lumen by advancing the pluralityof closure elements from an access and closure device associated with aguide wire positioned through the perimeter wall; advancing a tissuecutting element of the access and closure device along the guide wire tocause the tissue cutting element to penetrate through the perimeter wallto open an access site in the perimeter wall that includes a pluralityof tissue flaps, each of the plurality of tissue flaps having apredetermined geometry and attached to at least one of the plurality ofclosure elements; and inserting a medical instrument and/or a sheathinto the body lumen through the access site; removing the medicalinstrument and/or the sheath from the body lumen through the accesssite; and using the plurality of closure elements to close the accesssite.
 2. The method of claim 1, wherein: the tissue cutting elementcomprises a central rod and a plurality of blades positioned in acircumferential array around the central rod; and the plurality ofblades and the central rod are jointly penetrated through the perimeterwall to generate the access site.
 3. The method of claim 1, wherein: thetissue cutting element comprises a central rod and a plurality ofdeployable blades supported by the central rod and reconfigurablebetween a stowed configuration and a deployed configuration in which thedeployable blades are positioned in a circumferential array around thecentral rod; the tissue cutting element is penetrated into the bodylumen with the deployable blades in the stowed configuration; thedeployable blades are reconfigured from the stowed configuration to thedeployed configuration; and the tissue cutting element is retractedalong the guide wire with the deployable blades in the deployedconfiguration to cut the perimeter wall to form the plurality of tissueflaps.
 4. The method of claim 1, further comprising: exposing anexternal surface of the perimeter wall of the body lumen; and advancinga housing of the access and closure device along the guide wire intocontact with the external surface of the perimeter wall.
 5. The methodof claim 4, wherein advancing the tissue cutting element along the guidewire comprises advancing the tissue cutting element relative to thehousing while the housing contacts the external surface of the perimeterwall.
 6. The method of claim 5, comprising: advancing a plurality oftubes of the access and closure device along the guide wire relative tothe housing into contact with the external surface of the perimeter wallwhile the housing contacts the external surface of the perimeter wall;and ejecting the plurality of closure elements from the plurality oftubes into the body lumen through the perimeter wall.
 7. The method ofclaim 1, wherein the plurality of closure elements comprises a pluralityof sutures.
 8. The method of claim 7, wherein attaching the plurality ofclosure elements to the perimeter wall comprises: penetrating an end ofeach of the plurality of sutures through the perimeter wall; and pullingthe end of each of the plurality of sutures out of the body lumenthrough the access site via retraction of a suture drawing element. 9.The method of claim 8, wherein: the tissue cutting element comprises thesuture drawing element; and the suture drawing element is retracted byretracting the tissue cutting element.
 10. The method of claim 7,wherein the plurality of sutures are advanced through tissue overlyingthe perimeter wall of the body lumen.
 11. The method of claim 1, whereinthe plurality of closure elements comprises a plurality of metal clips.12. The method of claim 1, wherein the plurality of closure elements isejected from a respective plurality of tubes of the access and closuredevice.
 13. The method of claim 1, wherein the tissue cutting elementcomprises a lumen through which the guide wire extends.
 14. The methodof claim 1, wherein the plurality of closure elements is attached to theperimeter wall prior to advancing the tissue cutting element along theguide wire to generate the access site.
 15. The method of claim 1,wherein the plurality of closure elements is attached to the perimeterwall during advancement of the tissue cutting element along the guidewire to generate the access site.
 16. The method of claim 1, wherein theplurality of closure elements is attached to the perimeter wallsubsequent to advancing the tissue cutting element along the guide wireto generate the access site.
 17. The method of claim 1, whereinadvancing the tissue cutting element along the guide wire comprisesadvancing the tissue cutting element through tissue overlying theperimeter wall of the body lumen.
 18. The method of claim 1, wherein thetissue cutting element is advanced along the guide wire in a directionapproximately 45 degrees to a direction in which the body lumen extends.19. A method for opening and closing an access site in a blood vessel,the method comprising: positioning an access and closure device relativeto a blood vessel; advancing a plurality of closure elements from theaccess and closure device into the blood vessel; advancing a tissuecutting element of the access and closure device to penetrate the bloodvessel to open an access site in the blood vessel that includes aplurality of tissue flaps, each of the plurality of tissue flaps havinga predetermined geometry and penetrated by at least one of the pluralityof closure elements; and using the plurality of closure elements toclose the access site.
 20. The method of claim 19, further comprisingpenetrating a guide wire into the blood vessel through a perimeter wallof the blood vessel, wherein the tissue cutting element is advancedalong the guide wire.